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Clinical outcomes did not differ between men and women, but there remains an opportunity for more equitable treatment.

In the ISCHEMIA trial, women with chronic coronary artery disease received an overall lower intensity of guideline-based drug therapy (GDMT) than men, and thus were more likely to achieve different goals of risk factor management. The researchers reported that it was low.

Researchers led by Harmony Reynolds, M.D., NYU Langone Health, New York, found that women also have lower revascularization rates, which can be explained by a lower incidence of obstructive CAD on angiography; There was no difference in outcome between men and women.

Reynolds told TCTMD that it is surprising that drug treatment of female patients has not been more aggressive in the context of clinical trials, where algorithms for each treatment goal are included in the protocol, and where the trial sites It also included monitoring the performance of She said, “I didn’t expect achieving my goals to be so different.”

However, she noted that the undertreatment of women with coronary artery disease is a “known phenomenon” seen in previous studies, including other clinical trials. And it doesn’t seem to be associated with lower medication adherence in women. Women were slightly less adherent in the ISCHEMIA trial, she said, but the difference was not that large compared to men.

“I can’t help but think there is some kind of implicit bias. Of course, we can’t rule out that women want less intensive treatment, but this could be due to implicit bias among doctors. I feel that it may be related. [who think] Women are at lower risk,” Reynolds said. “As we’ve shown in this paper, women are not at lower risk. If they were to be treated as aggressively as men, perhaps that’s what they should do, but that doesn’t mean they’re at lower risk.”

The findings were published online this week. American Heart Association Journal“It’s another reminder that we need to pay attention to the goals of medical treatment at every patient visit,” Reynolds said. “We need to be more careful to ensure that all patients receive the same aggressive drug therapy for coronary artery disease. We know that medical therapy works, and we need to apply it rigorously.” need to do it.”

Gender differences in chronic coronary artery disease

Women with chronic coronary artery disease are generally older, have more comorbidities, and less obstructive CAD than men. However, previous studies have shown that the risk of adverse cardiovascular outcomes is similar.

Previous studies have also demonstrated that women with chronic coronary artery disease are less likely to undergo revascularization than men and may have poorer outcomes when they do undergo revascularization. It is unclear how much of this treatment disparity is attributable to differences in ischemic severity between men and women and whether protocolized treatment in the clinical trial setting influences disparities in the use of revascularization and GDMT. It is.

To investigate these issues, Reynolds et al. took a closer look at the ISCHEMIA trial. The study included 5,179 patients (median age 64 years, 22.6% female) with chronic coronary artery disease, preserved ejection fraction, and moderate to severe ischemia who were randomly assigned to participate in a stress test. became. Initial invasive strategy or conservative management.of Main results showed that the risk of adverse cardiovascular outcomes did not differ between strategies.

We need to be more careful to ensure that all patients receive the same aggressive drug therapy for coronary artery disease. harmony reynolds

The current analysis highlights several important differences between men and women in testing. In the invasive arm, women and men were similarly likely to receive catheterization, but women had lower revascularization rates at any time point during follow-up (73.4% vs. 81.2%; P < 0.001). This may be related to the less severe coronary artery disease in women, who are more likely to have no angiographic stenosis of 50% or more (12.3% vs. 4.5%) and to have multivessel stenosis. (60.0% vs. 74.8%) or less likely to have 3-vessel stenosis. Illness (29.8% vs 42.7%; P <0.001 overall) compared to men.

Catheterization rates were also similar by gender in the conservative arm of the trial. There was no difference in revascularization rates between women and men in this group as a whole, but in the catheter-treated subset, women had lower revascularization rates (72.3% vs. 82.3%). P = 0.007).

As seen in previous studies, overall GDMT utilization was lower among women than men, and fewer risk factor targets were achieved by the end of the study. For example, women were significantly less likely to achieve a systolic blood pressure goal < 140 mm Hg (73.6% vs 77.9%) or an LDL cholesterol goal < 70 mg/dL (50.2% vs 61.3%) and to be treated with aspirin. . Reynolds et al. report aspirin replacement (95.6% vs. 97.2%) "despite protocolized trial guidance regarding drug therapy." Of note, women were less likely than men to receive treatment with high-intensity statins (60.7% vs. 64.3%; P = 0.025), the rate of HbA1c levels reaching <8% was lower, but this was not a specific goal of treatment in this trial.

Reynolds said women scored lower on medication adherence measures than men, but the difference was not large.

“Detailed information regarding dose escalation according to blood pressure and laboratory values ​​in the ISCHEMIA trial is not accessible, but analysis of the relationship between risk factor target achievement and trial results is ongoing,” the researchers wrote. “Nonetheless, the urgent need to achieve equitable implementation of GDMT among women with chronic coronary artery disease is both an important challenge and an opportunity to improve clinical outcomes.”

room for improvement

Although the use of GDMT in women observed in this trial was suboptimal, the proportion of primary endpoints (CV death, MI, or hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest) was lower in both men and women. There was no difference between the two groups, and the rate was 14.8% for women. 14.3% in men (adjusted HR 0.93; 95% CI 0.77-1.13). Similar results were obtained for other outcomes, although perioperative MI was less common in women (1.0% vs 2.2%; adjusted HR 0.40; 95% CI 0.21-0.76), consistent with lower revascularization rates. I was doing it.

“It doesn’t seem like there’s much going on, but I think there’s quite a lot going on behind the scenes because women have less severe coronary artery disease. “It’s a strong predictor of outcome in blood status,” Reynolds said. However, offsetting the lower risk with comparable outcomes is that women are, on average, older, have a greater burden, and have less controlled risk factors.

In reality, such a contradiction should not exist. Eugenia Gianos

Eugenia Gianos, M.D. (Northwell Health, New York, NY), incoming chair of the American College of Cardiology’s Council on Cardiovascular Disease Prevention, agrees with that assessment and says the difference in GDMT strength between men and women is surprising. This is expected and unfortunate in the context of ischemia, even though such differences have been observed in previous studies.

She also mentioned the potential for bias on the part of treating physicians when explaining findings, but also that there may be differences due to patients declining or discontinuing medication. Stated.

But overall, “we still have a lot to learn about why there were these differences,” Gianos said, noting that a lower proportion of women participated in the trials and that the specific drugs used for GDMT and It pointed out that there was a lack of information regarding dosage. .

Nevertheless, “the reality is that today we have all the treatments we need to help people reach their goals, so there really shouldn’t be such a contradiction, and there should be no potential bias or latent…” Maybe we just need to educate health care workers more about this bias.” [about] It’s the barriers that patients face in terms of adherence and uptake,” Gianos said, calling for further high-level research focusing on gender differences.

To emphasize the importance of drug therapy in chronic coronary artery disease, Reynolds mentioned the treatment of heart failure due to reduced ejection fraction. The field is moving toward “more aggressive treatment earlier and increasing multiple drugs in a single visit. The sooner you reach your goal, the better the results. Perhaps the same here.” So instead of introducing things gradually, we need to focus on introducing the therapeutic arsenal and implementing it at a level where it’s immediately useful.”

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